Concomitant Tracheostomy and Lung Resection
Recruitment status was Recruiting
This protocol has been designed to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function|
- number of mechanical ventilation days after operation until discharge [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- 60 days mortality rate [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- ICU length of stay [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- hospital length of stay [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- cumulative incidence of postoperative respiratory complications defined as pneumonia, re-ventilation, atelectasis needing fiberbronchoscopy, non cardiogenic pulmonary edema, air leakage >7 days, broncho-pleural fistula, pulmonary embolism, empyema [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- laryngeal and tracheal complications [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
- general complications [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2001|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Background: Respiratory failure after lung resection is a major complication. Several studies suggest that low predictive postoperative pulmonary function is a predictive factor of mechanical ventilation (MV). In critically ill patients requiring MV, early tracheostomy may shorten the duration of MV and length of stay in intensive care.
Study objective: To determine whether concomitant tracheostomy (CT) would decrease the length of MV and improves outcome in patient with predictive postoperative forced expiratory volume in 1 second (FEV1ppo) < 50%. We call CT a tracheostomy performed immediately after the lung resection under the same general anesthesia.
Method: An open monocentric randomized controlled trial has been design. Inclusion and exclusion criteria are mentioned below. FEV1ppo will be calculated by the mean of the scintigraphic method for pneumonectomy and by the mean of the number of resected segments for lobectomy and segmentectomy. Randomization will be made the day before the operation. The procedure will be an open surgical tracheostomy. A daily data base will be completed from randomization until discharge. The primary and secondary criteria are mentioned below.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053624
|Contact: Patrick Lacarin||04 73 75 11 email@example.com|
|Clermont-Ferrand, France, 63003|
|Contact: Patrick Lacarin 04 73 75 11 95 firstname.lastname@example.org|
|Principal Investigator:||Marc Filaire, MD||University Hospital, Clermont-Ferrand|